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J.-A. C. Pournaras, A. Mermoud; Safety and Efficacy of the New Optonol Microtube (Ds Version) Combined With Modified Deep Sclerectomy in POAG Patients: Preliminary Results. Invest. Ophthalmol. Vis. Sci. 2007;48(13):818.
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To assess the safety and efficacy of the new Optonol microtube (DS version) combined with modified deep sclerectomy in POAG patients.
This single center, non-randomized, prospective pilot study include 9 POAG patients (10 eyes) requiring filtering surgery. Deep sclerectomy was performed and the miniature implant was inserted at the anterior part of the deep sclerectomy into the anterior chamber. The complete eye evaluation was performed before and after surgery during 12 months. UBM were also performed.
10 eyes of 9 patients were included. The mean follow-up period was 10.8 months (from 6 to 12 months). At the sixth and the twelfth months, the mean postoperative intraocular pressure was significantly reduced from 20.2 ± 2.86 mmHg to 11 ± 3.2 mmHg (p<0.0001; n=10), and to 12.38 ± 2.5 (p=0.0009; n=8), respectively. The mean number of glaucoma medications before surgery was 2 (range 1 to 3). At twelfth month, one patient required additional medication.Postoperative complications included transient microhyphaema (n=5), and cysts formation leading to mitomycin use and needling procedure (n=2). Two cases presented a Seidel requiring suture. No inflammatory response persisted after surgery. One patient presented persistent hypotony without choroidal detachment. Fibrosis of the implants aperture in the anterior chamber was never observed. All implants were correctly placed and drainage pathways were shown by the UBM.
The new Optonol microtube (DS version) combined with modified deep sclerectomy is well tolerated and significantly reduces the intraocular pressure at the sixth and twelfth months without any notable complication. Further clinical studies are needed in order to assess these preliminary results.
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